Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today announced that seven oral and four poster presentations detailing updated clinical and preclinical results generated in partnership with its collaborators will be presented at the 58 th American Society of Hematology (ASH) Annual Meeting. Senior executives will also review results and provide an update on Juno's clinical development program at an analyst and investor event, which will also be available via webcast. "Presentations at ASH will showcase new data that support our best-in-class CAR T strategy across a range of B-cell malignancies," said Mark J. Gilbert, M.D., Juno's Chief Medical Officer. "The responses we are seeing with our product candidates, including updated JCAR017 results in adults with relapsed/refractory NHL, demonstrate the potential of our CAR T programs for patients in need of more treatment options. We are also learning more about cell characterization and toxicities, which are critical to improving the patient experience, our product candidates' benefit-to-risk ratio, and potentially moving CAR T treatment into earlier lines of therapy." New data with JCAR017 in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), which is a subtype of NHL, and final data from the PLAT-02 trial for pediatric patients with relapsed/refractory acute lymphoblastic leukemia (ALL) will be presented. JCAR017 uses a defined CD4:CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates advancing to commercialization. In addition, final data from a Phase I trial with JCAR014 in high-risk, ibrutinib-refractory patients with chronic lymphocytic leukemia (CLL) will also be presented in an oral presentation. The following will be presented at ASH: Oral Presentations CD19 CAR T Cells Are Highly Effective in Ibrutinib-Refractory Chronic Lymphocytic Leukemia (Abstract #56)Presenter: Cameron J. Turtle, M.B.B.S., Ph.D., Fred Hutchinson Cancer Research Center Date: Saturday, December 3, 2016, 7:45 a.m. Pacific TimeLocation: San Diego Convention Center, Room 6AB Implications of Concurrent Ibrutinib Therapy on CAR T-Cell Manufacturing and Phenotype and on Clinical Outcomes Following CD19-Targeted CAR T-Cell Administration in Adults with Relapsed/Refractory CLL (Abstract #58)Presenter: Mark B. Geyer, M.D., Memorial Sloan Kettering Cancer Center Date: Saturday, December 3, 2016, 8:15 a.m. Pacific TimeLocation: San Diego Convention Center, Room 6AB CD19 CAR T Cell Products of Defined CD4:CD8 Composition and Transgene Expression Show Prolonged Persistence and Durable MRD-Negative Remission in Pediatric and Young Adult B-Cell ALL (Abstract #219)Presenter: Rebecca Gardner, M.D., Seattle Children's Research Institute Date: Saturday, December 3, 2016, 4:30 p.m. Pacific TimeLocation: Marriott Marquis San Diego Marina, Marriott Grand Ballroom Salons 11-13 Minimal Residual Disease Negative Complete Remissions Following Anti-CD22 Chimeric Antigen Receptor (CAR) in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (Abstract #650)Presenter: Nirali Shah, Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute Date: Monday, December 5, 2016, 7:15 a.m. Pacific TimeLocation: San Diego Convention Center, Room 6CF Creation of The First Non-Human Primate (NHP) Model That Faithfully Recapitulates Chimeric Antigen Receptor (CAR) T cell-mediated Cytokine Release Syndrome (CRS) and Neurologic Toxicity Following B Cell-directed CAR T Cell Therapy (Abstract #651)Presenter: Agne Taraseviciute, Seattle Children's Research Institute Date: Monday, December 5, 2016, 7:15 a.m. Pacific TimeLocation: San Diego Convention Center, Room 6CF Decreased Rates of Severe CRS Seen with Early Intervention Strategies for CD19 CAR T Cell Toxicity Management (Abstract #586)Presenter: Rebecca Gardner, M.D., Seattle Children's Research Institute Date: Monday, December 5, 2016, 7:45 a.m. Pacific TimeLocation: Marriott Marquis San Diego Marina, Marriott Grand Ballroom Salons 2-4 EBV-Specific Donor Cells Transduced to Express a High-Affinity WT1 TCR Can Prevent Recurrence in Post-HCT Patients with High-Risk AML (Abstract #1001)Presenter: Aude G. Chapuis, M.D., Fred Hutchinson Cancer Research Center Date: Monday, December 5, 2016, 3:45 p.m. Pacific TimeLocation: San Diego Convention Center, Room 24 Poster Presentations Biomarkers of Cytokine Release Syndrome and Neurotoxicity after CD19 CAR-T Cells and Mitigation of Toxicity by Cell Dose (Abstract #1852)Presenter: Cameron J. Turtle, M.B.B.S., Ph.D., Fred Hutchinson Cancer Research Center Date: Saturday, December 3, 2016, 5:30 p.m. - 7:30 p.m. Pacific TimeLocation: San Diego Convention Center, Hall GH Preclinical Analyses Support Clinical Investigation of Combined Anti-CD19 CAR-T Cell, JCAR017 with Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia (Abstract #3231)Presenter: Jim Qin, Senior Research Associate, Juno Therapeutics Date: Sunday, December 4, 2016, 6:00 p.m. - 8:00 p.m. Pacific TimeLocation: San Diego Convention Center, Hall GH Transcend NHL 001: Immunotherapy with the CD19-Directed CAR T Cell Product JCAR017 Results in High Complete Response Rates in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (Abstract #4192)Presenter: Jeremy S. Abramson, Massachusetts General Hospital Cancer Center Date: Monday, December 5, 2016, 6:00 p.m. - 8:00 p.m. Pacific TimeLocation: San Diego Convention Center, Hall GH Identification of Small Molecule Modulators to Enhance the Therapeutic Properties of Chimeric Antigen Receptor T Cells (Abstract #4712)Presenter: Jonathan Rosen, Ph.D., Senior Director, Research & Technology Core, Fate Therapeutics Date: Monday, December 5, 2016, 6:00 p.m. - 8:00 p.m. Pacific TimeLocation: San Diego Convention Center, Hall GH ASH Investor and Analyst Event and Webcast The Juno ASH Investor and Analyst Event and webcast will be held Monday, December 5, 2016 at 8:30 p.m. Pacific Time. The webcast can be accessed live on the Investor Relations page of Juno's website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the event. ABOUT JUNO Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute, the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children's Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children's Research Hospital.
FORWARD-LOOKING STATEMENTSThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno's mission, progress, and business plans, clinical trial results and the implications thereof, the possibility of improving the patient experience and the benefit-to-risk ratio of CAR T treatment, the potential to move CAR T treatment into earlier lines of therapy, and the timing and content of planned presentations at ASH. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno's CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno's dependence on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 5, 2016 and Juno's other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.